Kornimate/medical-research-clean huggingface dataset:
clinical investigation of visual function after bilateral implantation of two presbyopia-correcting trifocal intraocular lenses (iol)

Conditions: Cataracts

Summary: the purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting trifocal iols.

subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.

Eligibility criteria:
inclusion criteria: * diagnosis of bilateral cataracts with planned clear cornea cataract removal; * able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; * calculated lens power between 13.0 and 30.0 diopters (d); * preoperative best-corrected distance visual acuity (bcdva) worse than 0.20 logmar (ie, 0.22 logmar or worse) in at least one eye; * potential postoperative bcdva of 0.20 logmar or better in both eyes. note: subjects with any pathology that could reduce visual potential should not be enrolled in this trial; * preoperative regular corneal astigmatism of \< 1.00 d, in both eyes; * clear intraocular media other than cataract in both eyes; * other protocol-specified inclusion criteria may apply. exclusion criteria: * reasonably expected to require an ocular surgical treatment at any time during the study (other than yag capsulotomy); * previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to lasik, astigmatic keratotomy and limbal relaxing incisions); * clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema; * amblyopia; * previous corneal transplant; * any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction; * rubella, congenital, traumatic, or complicated cataracts; * glaucoma (uncontrolled or controlled with medication); * degenerative eye disorders; * history of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy; * optic nerve atrophy; * expected to require retinal laser treatment; * color vision deficiencies; * pregnant or lactating (current or planned during the course of the study); * other protocol-specified exclusion criteria may apply.
influence of short-term vojta therapy on the gait in healthy adult subjects.

Conditions: Gait, Frontal

Summary: the patterns of reflex locomotion described by vojta contain all the basic patterns necessary for gait, which can be observed as partial patterns during normal postural ontogenesis in the first year of life. these patterns are triggered throughout life regardless of age, so they can be activated both in healthy subjects and in the presence of neurological pathology in adult patients.

in reflex locomotion, there is a coordinated and rhythmic activation of the entire skeletal muscles and different circuits of the central nervous system are stimulated. the motor reactions that are triggered regularly and cyclically due to pressure stimuli, from certain starting positions, are completely reproducible and as often as desired, even in the newborn child. all the movements that appear in the development of the human being in grasping, turning, crawling, standing up and walking, are therefore visibly stimulated. they are, according to prof. vojta, present even in children of a developmental stage, in which they do not spontaneously yet possess these capacities. through the therapeutic application of reflex locomotion, those muscular functions used unconsciously and necessary for spontaneous daily motor skills are activated in the patient, especially in the spine, but also in the arms and legs, hands and feet and in the face.

Eligibility criteria:
inclusion criteria: * to be over 18 years old. exclusion criteria: * present limitations or permanent or temporary injuries to the locomotor system.

Keywords: gait reflex locomotion core stability ontogenesis neurorehabilitation neurological disorder
comparing tolerability and absorption of racemic and r-lipoic acid in progressive multiple sclerosis

Conditions: Multiple Sclerosis; Progressive Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis

Summary: this is a three-week crossover study that will compare how the body absorbs and tolerates two different forms of lipoic acid: r form and racemic form.

this three-week double-blind crossover trial will compare two different forms of lipoic acid (la). every participant will take one week of daily oral 600mg r la, have a one week washout period without la, and take one week of daily oral 1200mg racemic la. the order of la type will be determined by randomization. blood analyses will be performed to determine which form is better absorbed and a side effects questionnaire will be completed at each visit in order to determine which form is better tolerated.

Eligibility criteria:
inclusion criteria: * diagnosis of progressive multiple sclerosis * 18 years of age or older * able to give informed consent and adhere to the study activities * able to swallow large oral capsules exclusion criteria: * clinical multiple sclerosis relapse in the prior 1 year * oral or iv steroids in the prior 3 months * have taken la in last 30 days * clinically significant kidney disease as determined by the pi including, but not limited to, major kidney disease diagnoses, abnormal laboratory values related to renal function, or other related conditions * insulin-dependent diabetes * other significant ongoing medical illness that may interfere with study procedures * taking oral anticoagulants (e.g. coumadin). aspirin, clopidogrel, and dipyridamole are acceptable to take * pregnant or breast-feeding * any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
rise program for nurses

Conditions: Stress, Psychological

Summary: the purpose of this study is to determine whether the rise program has a significant impact on nurses' resilience, insight, self-compassion, and empowerment, as well as mental and physical well-being, in their personal lives and their working environment.

this study will include the face-to-face visits of eight weekly 90-minute psychoeducational group sessions in a private conference room at adventhealth. no absences are permitted due to lack of engagement. participants will only be compensated for the number of attended sessions. the lmhc facilitator will send a reminder email to the control group participants after the intervention group participants attend their eighth session. there will be three unpaid optional follow-up monthly booster sessions that focus on skill development. participants will be invited to attend these booster sessions during the 3 months following their group's rise program. attendance will be recorded. no other data will be collected during the booster sessions. the following assessments will be used to measure study outcomes: brief resilience scale (brs); self-reflection and insight scale (sris); self-compassion scale - short form (scs-sf); psychological empowerment instrument (pei); stress mindset measure - general (smm-g); perceived stress survey (pss); maslach burnout inventory (mbi); public health surveillance - wellbeing scale (phs-wb); rand mos sleep scale survey; rand 36-item short form health survey (sf-36); world health organization health and work performance questionnaire (who-hpq); and work productivity and activity impairment (wpai) questionnaire. in addition, demographic assessments will be collected. employment with adventhealth will also be tracked longitudinally at 12 months with human resources.

Eligibility criteria:
inclusion criteria: 1. adult ≥ 18 years old 2. licensed as an rn 3. rn employed by adventhealth in a hospital-based setting at the altamonte, apopka, celebration, daytona beach, deland, east, fish memorial, kissimmee, new smyrna beach, orlando, palm coast, waterman, or winter park campus 4. able to speak, read, and understand english fluently 5. able to provide informed consent 6. willing and able to comply with all study procedures and requirements for the duration of the study. exclusion criteria: 1. employed as an arnp 2. employed in a role that completes another rn's annual evaluations 3. a participant of the study in irbnet #1234568 or irbnet #1256670 4. at imminent risk of harm to themselves or others.
sitagliptin improved beta cell function and prevented a conversion rate to impaired glucose tolerance and type 2 diabetes in metformin intolerant obese women with polycystic ovary syndrome

Conditions: PCOS

Summary: metformin is the first-line therapy for pcos with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. the alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. our aim was to evaluate whether sitagliptin (sita) preserves metabolic profile in metformin (met) intolerant pcos with high metabolic risk.


Eligibility criteria:
inclusion criteria: * 18 years old to menopause * polycystic ovary syndrome (asrm-eshre rotterdam criteria) * bmi of 30 kg/m2 or higher exclusion criteria: * significant cardiovascular disease * significant kidney or hepatic disease * personal or family history of medullary thyroid carcinoma * known history of gallbladder disease * known history of pancreatitis

Keywords: metformin intolerance pcos sitagliptin beta cell function
continuous saphenous block versus continuous femoral block for total knee arthroplasty

Conditions: Total Knee Arthroplasty Secondary to Osteoarthritis

Summary: strength of the quadriceps muscle is key to recover from total knee arthroplasty. in this study we compare two techniques for pain control after total knee arthroplasty in terms of preserving the motor function (the strength of the quadriceps muscles of the thigh) which will facilitate the rehabilitation and accelerate the hospital discharge. we will use ultrasound guided technique to block either the femoral nerve in the control group or the saphenous nerve in the experimental group. the primary outcome is the functional capacity and the impact of each block on the ability to walk by measuring the distance patients are able to walk in two minutes in post operative day one in the two groups. the secondary outcome is the morphine consumption in the two groups.


Eligibility criteria:
inclusion criteria: - subject age over 18 years coming for total knee arthroplasty secondary to osteoarthritis exclusion criteria: * asa 4-5 * abnormal liver enzymes, hepatic failure, renal failure and cardiac failure if they become contraindication for the use of regional anesthesia * contraindications for spinal anesthesia * morbid obesity * organ transplant * neuropathic pain * history of stroke or major neurological deficit * sensory and motor disorders in the operated limb * previous drug dependency * chronic use of opioids * allergy to local anesthetics * inability to comprehend pain assessment
human mesenchymal stromal cells for acute respiratory distress syndrome (start)

Conditions: Respiratory Distress Syndrome, Adult

Summary: this was a phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of allogeneic bone marrow-derived human mesenchymal stromal cells (hmscs) infusion in patients with acute respiratory distress syndrome (ards).

we carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ards in 60 patients, 40 msc and 20 placebo, in a 2:1 randomization. this trial is the extension of the phase 1 pilot trial (nct01775774). patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. vital status was collected at 6 and 12 months after study enrollment.

Eligibility criteria:
inclusion criteria: patients will be eligible for inclusion if they meet all of the below criteria. criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment: acute onset (defined below) of: 1. a need for positive pressure ventilation by an endotracheal or tracheal tube with a pao2/fio2 ratio \< 200 with at least 8 cm h2o positive end-expiratory airway pressure (peep) 2. bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph 3. no clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates. exclusion criteria: 1. age less than 18 years 2. greater than 96 hours since first meeting ards criteria per the berlin definition of ards 3. pregnant or breast-feeding 4. prisoner 5. presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years 6. any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% 7. moderate to severe liver failure (childs-pugh score \> 12) 8. severe chronic respiratory disease with a paco2 \> 50 mm hg or the use of home oxygen 9. patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest) 10. major trauma in the prior 5 days 11. lung transplant patient 12. no consent/inability to obtain consent 13. moribund patient not expected to survive 24 hours 14. world health organization (who) class iii or iv pulmonary hypertension 15. documented deep venous thrombosis or pulmonary embolism within past 3 months 16. no arterial line/no intent to place an arterial line 17. no intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol 18. currently receiving extracorporeal life support (ecls) or high-frequency oscillatory ventilation (hfov)

Keywords: allogeneic bone marrow-derived human mesenchymal stromal cells acute respiratory distress syndrome
online psychological support group for patients with heart failure and depression

Conditions: Heart Failure; Depression

Summary: heart failure is a chronic disease, being the second cause of death in brazil. currently, it is estimated that 6.4 million brazilians suffer from this disease. the higher number of rehospitalization, lower survival of these individuals. there are recommendations from societies of cardiology for the inclusion of effective self-care for patients with chronic hf, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. one of the pillars of self-care's education for chronic patients recommended by the health ministry is the management of the patient's emotional aspects. these have been undertreated in most studies. the prevalence of depression among patients with hf is high and ranges from 41% to 72%, and the assessment with the bdi-ii, which is the gold standard used, is 67%. patients with hf and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. also, they present 4 times more risk of rehospitalization/mortality. faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.


Eligibility criteria:
inclusion criteria: * patients diagnosed with heart failure * age between 18 and 79 years b) * after hospital discharge * depression (bdi-ii score above 14 points) * acceptance of the term of consent; exclusion criteria: * patients with dementia * communication barriers * octogenarians * people unable to access the internet for the intervention * who declined to participate;
a phase iii study of pa21 with calcium carbonate in hemodialysis patients with hyperphosphatemia

Conditions: Hemodialysis; Hyperphosphatemia

Summary: the purpose of this study is to investigate the safety and efficacy when administering pa21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.


Eligibility criteria:
inclusion criteria: * receiving stable maintenance hemodialysis 3 times a week * dialysis patients with hyperphosphatemia exclusion criteria: * patients having history of a pronounced brain / cardiovascular disorder * patients having severe gastrointestinal disorders * patients having severe hepatic disorders

Keywords: hemodialysis hyperphosphatemia
sweet taste receptors and the secretion of glucagon-like peptide-1 and peptide yy

Conditions: Appetite and General Nutritional Disorders; Hormone Replacement

Summary: the purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gi satiety peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gut.

there is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. it is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (glp-1) and peptide yy (pyy). several nutrient responsive g-protein coupled receptors have been identified in the human gut, including the sweet taste responsive t1r2/t1r3 heterodimer, the amino acid/umami responsive t1r1/t1r3 as well as gpr120 for unsaturated long-chain free fatty acids.the functional significance of sweet taste receptors in glucose stimulated secretion of glp-1 and pyy will be determined by intragastric infusion of 75 g glucose with different concentrations of lactisole (150 ppm, 300 ppm and 450 ppm)in a double blind, 4-way crossover trial including 16 healthy subjects.

Eligibility criteria:
inclusion criteria: * healthy subjects * bmi of 19.0-24.5 * age 18-40 * stable body weight for at least 3 month exclusion criteria: * smoking * substance abuse * regular intake of medication * medical or psychiatric illness * gastrointestinal disorders or food allergies
serum interleukin -21 level in patients with severe adverse cutaneous drug reaction.

Conditions: Adverse Cutaneous Reaction to Alternative Medical Therapy

Summary: adverse cutaneous drug reactions are undesirable and typically unanticipated reactions independent of the intended therapeutic purpose of a medication. it may be either immunologic (eg, drug allergy) or non-immunologic. adverse cutaneous drug reaction produce a wide range of clinical manifestations such as pruritus, maculopapular eruptions, urticaria, angioedema, phototoxic and photo allergic reactions, fixed drug reactions, erythema multiforme,vesiculobullous reactions (eg, stevens-johnson syndrome and toxic epidermal necrolysis) and serum sickness .they must be considered in the differential diagnosis of sudden symmetric eruption

erythema multiforme is an acute immune mediated disorder it is a type iv hypersensitivity reaction leading to dermal vasculitis. erythema multiforme major usually as a result of medications such as sulphonamides, non-steroidal anti-inflammatories and penicillin and there is skin and mucosal involvement. steven-johnson syndrome (sjs) and toxic epidermal necrolysis (ten) are considered a spectrum of acute life-threatening mucocutaneous reactions that differ only in severity. both diseases are characterized by mucous membrane and skin involvement, are often caused by medications and are collectively known as epidermal necrolysis or scalded skin syndrome.stevens-johnson syndrome (sjs) is classified as an epidermal loss \ 30% body surface area erosion. the range of epidermal loss between 10% and 30% is called stevens-johnson syndrome-toxic epidermal necrolysis (sjs-ten) overlap. severity of illness score \[score of toxic epidermal necrolysis(ten) \] has been devised to predict prognosis in patients with epidermal necrolysis.this scoring system addresses 7 prognostic factors: age, malignancy, heart rate,body surface area involved, serum urea, serum glucose and serum bicarbonate levels. interleukin-21 regulates both innate and adaptive immune responses and it is not only has key roles in antitumour and antiviral responses that promote the development of autoimmune diseases and inflammatory disorders. it is recently discovered member of the type 1 cytokine family which is produced by activated clusters of differentiation 4+ t cells ,natural killer cells and follicular helper t cells.

Eligibility criteria:
inclusion criteria: * 20 patients presenting with adverse cutaneous drug reaction (erythema multiforme, sjs and ten ) * patients with definite drug history. * both sex will be included. exclusion criteria: * patients with a history of topical or systemic treatment (corticosteroids, intralesional steroid injection, immunosuppressive therapy). * patients within 4 weeks of the study. * patients receiving phototherapy within 6 months of the study. * diabetic patients * anaemic patients * thyroid disorders, * chronic liver or renal diseases * atopy and parathyroid disorders. * patients with known autoimmune diseases or cancer. * pregnant or lactating womens.
trendelenburg position for acute anterior circulation ischemic stroke with large artery atherosclerosis etiology (hopes 3)

Conditions: Stroke, Acute Ischemic

Summary: the effect of head position as a nonpharmacological therapy on acute ischemic stroke (ais) remains inconclusive. recent hopes2 (head down-position for acute moderate ischemic stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (hdp) in acute ischemic stroke. the current study aims to investigate the efficacy and safety of hdp in acute moderate ischemic stroke patients with large artery atherosclerosis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * acute ischemic stroke confirmed by ncct or mri; * moderate neurologic deficit (6≤ nihss ≤ 16) within 24 hours of onset, or progressing from mild (nihss ≤ 5) to moderate neurologic deficit (6≤ nihss ≤ 16) within 24 hours, requiring ≥ 4 point increase in nihss score although the onset time is beyond 24 hours; * probable large artery atherosclerosis etiology based on the trial of org 10172 in acute stroke treatment (toast) criteria (responsible artery stenosis ≥ 50% or occlusion); * anterior circulation stroke (internal carotid artery, m1 or m2 of middle cerebral artery); * first stroke onset or past stroke without obvious neurological deficit (mrs≤2); * signed informed consent. exclusion criteria: * pre-stroke disability (mrs≥3); * patients with disturbance of consciousness; * patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy; * hemorrhagic stroke or combined ischemic and hemorrhagic stroke; * serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc; * other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc; * previous history of intracerebral hemorrhage within 1 year; * any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure); * planned carotid or intracranial revascularization within 3 months; * severe uncontrolled hypertension (systolic blood pressure over 180mmhg or diastolic blood pressure over 100 mmhg); * cardiac insufficiency (nyha class ≥ii); * pregnant or lactating women; * comorbidity with other serious diseases; * participating in other clinical trials within 3 months; * patients not suitable for the study considered by researcher.